Regional Regulatory Affairs Lead, US

The role

You will build the US regulatory affairs function from the ground up. You will manage the relationship with the FDA and hold statutory roles including US Agent, Initial Importer, and Medical Device Distributor.

What you will do

• Set up the US RA function including core processes, SOPs, and a live, in-region quality management system.
• Manage the relationship with FDA, including device submissions and regulatory pathway implementation.
• Build a scalable, state-by-state expansion process.
• Hold the US Agent, Initial Importer, and Medical Device Distributor roles.
• Manage post-market regulatory activity for the region.
• Help shape US and global RA strategy and define the future US team.

Required qualifications

• 8+ years in medical device regulatory affairs, with at least 5 focused on FDA-regulated devices.
• Track record as the accountable lead on US clearances or approvals: 510(k), De Novo, or PMA.
• Direct FDA engagement: planned and led pre-submission and submission meetings.
• Eligibility and willingness to hold the US Agent, Initial Importer, and Medical Device Distributor roles.
• Experience building processes, SOPs, or teams in a scale-up or greenfield setting.
• Experience supporting clinical expansion into new markets or sites.
• Solid grasp of the operations behind expansion from in-region setup to scaling day-to-day delivery.
• Hands-on experience using AI for regulatory and market intelligence, documentation preparation, and workflow automation.
• A degree in a relevant field.

Nice to have

• Software as a Medical Device (SaMD) experience alongside a hardware device background.
• Experience partnering with product development in medtech or healthtech engineering.
• Experience building or scaling a regional regulatory team.

Benefits

• Base salary
• Equity
• Full benefits

About the company

Neko is redefining what prevention means by making data-driven, preventative care accessible through proprietary technology and direct clinical care.